spray drying technology

Pioneered for pharmaceutical applications by Bend Research (now Lonza), spray drying has emerged as a primary technology for addressing poor dissolution rate, solubility and bioavailability. Spray-dried dispersions represent an established approach in bringing an increasing number of BCS II compounds to market.  We have premier expertise and capability in spray drying, with integrated capabilities in place to support proof-of-concept through commercial scale manufacture of spray-dried dispersions or finished drug products based on these intermediates.

The majority of today’s drug candidates have low aqueous solubility (BCS II), and require an enabling technology to enhance oral bioavailability.  Amorphous solid dispersion approaches utilizing spray dried dispersion (SDD) technology offer a proven and highly flexible approach to significantly improve the bioavailability of promising BCS ll compounds.

Spray drying is also increasingly utilized for dry powder inhaler (DPI) applications, providing particle engineered formulations in the required particle size distribution to meet target product profiles.

Our Bend (OR) site is our Center of Excellence for solid dispersions.  The site is equipped with a full range of processing capabilities for spray drying, as well as hot-melt extrusion.  Bend also has extensive capabilities in developing and manufacturing finished drug products in monolithic or multiparticulate formats.

Spray drying expertise

A spray dried dispersion (SDD) is a single-phase, amorphous molecular dispersion of a drug in a polymer matrix. It is a solid solution with the compound molecularly “dissolved” in a solid matrix. As the name suggests, SDDs are obtained by dissolving drug and polymer in an organic solvent and then spray drying the solution. The formulation and process conditions are chosen so that the solvent quickly evaporates from the droplets, allowing insufficient time for phase separation or crystallization. In addition to their proven performance in enhancing solubility, SDDs have demonstrated long-term stability, facile scale-up and excellent manufacturability.

Our SDD technology platform incorporates compositions, processes and finished dosage forms designed to meet performance, stability and manufacturing requirements for a diverse range of compounds. Our extensive experience developed over a 25+ year track record has resulted in multiple advancements:

• Expanded application space for SDD technology
• Technology selection models and polymer selection tools for accelerated development
• Processing advancements and specialized spray dryer designs for optimized efficiency
• Science-of-scale studies facilitating rapid scale-up from proof of concept

Drug product intermediates based on SDD technology can be formulated into capsule, tablets and other solid dosage forms. With our integrated product development approach, we can efficiently develop and manufacture SDDs and dosage forms for all stages of development and commercial scale production.

• Proprietary mini-spray drying equipment designed for feasibility assessments and prototype development based on minute quantity of API (as low as 100 mg)
• Non-GMP development facility to support rapid product development
• Small-to-mid sized spray dryers for scale-up, QBD studies and production of toxicology study supplies
• Commercial scale spray dryers in non-GMP environment for seamless process development and commercial scale-up to GMP
• GMP production capabilities for manufacture of registration lots, commercial launch quantities and ongoing supply of SDD intermediate